Biomedical Auditor Certification CBA
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Biomedical Auditor CBA


Who Should Certify?

The Certified Biomedical Auditor is a professional who understands the principles of standards, regulations, directives, and guidance for auditing a biomedical system while using various tools and techniques to examine, question, evaluate, and report on that system's adequacies and deficiencies.

A biomedical auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety.

Please Note: The Certified Biomedical Auditor (CBA) program will be renamed to the Certified Medical Device Auditor (CMDA) program starting November 1st, 2020.

Download the 2013 CBA BoK or 2020 CMDA BoK (Effective November 2020).

Download the CBA Fact Sheet or CMDA Fact Sheet.


COST

ASQ Members $398 (save $100)

Non-members $498
Retakes $298


Download an Application (CBT).


NEXT CBT TESTING WINDOW

November 1 - 30, 2020

Application Deadline: October 9, 2020


View All Test Dates and Options


ASQ Biomedical Auditor


Requirements

Candidates must have worked in a full-time, paid role. Paid intern, co-op or any other course work cannot be applied toward the work experience requirement.

5

Years of on-the-job experience in one or more areas of the Certified Biomedical Auditor Body of Knowledge.

1

*Year of on-the-job experience must be in a "Decision-making" position.

*A "Decision-making" position is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions.



Education

Candidates who have completed a degree from a college, university or technical school with accreditation accepted by ASQ will have part of the five-year experience requirement waived, as follows (only one of these waivers may be claimed):

  • Associate degree — one year waived
  • Bachelor's degree — three years waived
  • Master's or doctorate — four years waived

Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.



Prepare for the exam

Review a list of references that provide the basis for the exam questions. These items give you a better idea of the material covered in the exam. ASQ offers many books and training opportunities to help you prepare.


CBA Question Bank

The CBA Question Bank provides sample exam questions based on the CBA Body of Knowledge. Includes simulated timed exam and review modes.


CBA Handbook

The Certified Biomedical Handbook is a companion guide to your exam's Body of Knowledge. The handbook can be used during your open-book exam!


CBA Certification Preparation


Examination

Each candidate is required to pass an exam that consists of multiple-choice questions that measure comprehension of the Body of Knowledge.

Computer Delivered - The CBA examination is a one-part, 145-multiple choice question exam, and is offered in English only. 135 questions are scored and 10 are unscored. Total appointment time is four-and-a-half-hours, exam time is 4 hours and 18 minutes.

Paper and Pencil - The CBA examination is a one-part, 135- multiple choice question, four-hour exam and is offered in English only.

All examinations are open book. Each participant must bring his or her own reference materials. Use of reference materials and calculators is explained in the FAQs.

For more information about examination delivery options, including online, remote proctored examination, please visit the computer-based testing page.

 

What Happens if I pass/fail?

PASS

If taking the exam CBT you will get your result immediately after submitting the exam. Within 3-5 business days you will receive an email confirming the result. ASQ will mail your hardcopy certificate. Delivery estimates for your certificate are 1-2 weeks (US & Canada), 6-8 weeks (International mailing).

ASQ communicates exam results for exams with updated or new Bodies of Knowledge (pilot exams) within five weeks.

FAIL

If you do not pass your CBT exam you will receive a summary of your performance via email within 3-5 business days from your initial exam. For 2 years from your previous attempt you can apply at a significantly reduced "retake rate". (Please see Exam Results FAQs for additional details.)
Results for Paper-based tests will be slightly delayed.



Body of Knowledge

Included in the Body of Knowledge are subtext explanations and corresponding cognitive levels for each subtopic. These details will be used by the Examination Development Committee as guidelines for writing test questions and are designed to help candidates prepare for the exam by identifying specific content within each topic that may be tested.

The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam, but is intended to clarify how topics are related to the role of the certified biomedical auditor. The descriptor in parentheses at the end of each subtext entry refers to the highest cognitive level at which the topic will be tested. A more complete description of cognitive levels is provided at the end of the document.

Please Note: The Certified Biomedical Auditor (CBA) program recently underwent a Body of Knowledge refresh and starting in the November 2020 testing window, the program will be renamed to the Certified Medical Device Auditor (CMDA) and the new Body of Knowledge will be tested. Please read our Body of Knowledge Map that details the refresh process, and the differences between the 2012 CBA BoK and 2020 CMDA BoK.

Download the Certified Biomedical Auditor Body of Knowledge


Policies and Procedures

Identification Policies

Identification Policy

You will be required to present one valid, government-issued photo ID with a signature (e.g., driver's license or passport).

The ID you bring must match your name as stated on your application.

All of your personal belongings will be placed in your temporary Prometric locker during your time in the test center. You will be permitted to keep your ID and your locker key with you at all times.

Calculator Policies

Calculator Policy

All computer-based exams feature a basic scientific calculator on-screen in the exam. Prometric Test Center Administrators can provide you with a hand-held basic calculator upon request.

Any silent, hand-held, battery-operated calculator with no programmable memory will be permitted. Programmable calculators tend to have graphing capabilities, the ability to store text/alphanumeric data by the input of the user, and a function (fn, F1, F2, etc.) button.

Calculators such as the Texas Instruments TI-89 or similar are absolutely not allowed because they are programmable.

References/Open Book Policy

References/Open Book Policy

Prometric will provide you scratch paper and pencils.

All ASQ exams are open book and all reference materials (including all forms of notes) must be bound and remain bound during the exam.

Bound refers to material permanently bound by stitching or glue and materials fastened securely in its cover by fasteners, which penetrate all papers (i.e., ring binders, spiral binders, plastic snap binders, brads, or screw posts).

Manually or hand-stapled documents that are not securely fastened in their covers are not allowed.

Before you enter the exam room, the Test Center Administrator (TCA) will inspect all references. "Post-Its" will be permitted as book tabs only (must be attached prior to entering the test center).

Arrival Time

Arrival Time

Plan to arrive 30 minutes before the scheduled appointment to allow time for check-in procedures. If you are late in arriving, you will not be allowed to test and will forfeit your exam fee.

Absences, Cancellations, Reschedules

Absences, Cancellations, Reschedules

If you wish to change your exam appointment date or time, you must do so at least five days prior to your appointment using the Reschedule/Cancel option on Prometric's website, or by contacting Prometric's automated voice response system. There is a $70 fee for changing an appointment. Failure to appear for your exam appointment will result in a loss of all applications fees.

Prohibited Items

Prohibited Items

Items strictly prohibited in the exam area: hand-stapled materials, blank writing tablets or tablets containing blank pages, unbound tablets, unbound notes, slide charts and/or wheel charts (hand-held cardboard or plastic calculating devices with rotating or sliding pieces).

Application Process & Timeline

1. Submit your application:
Application review takes 1-2 business days for online applications and 3-5 for hardcopy applications.

2. ASQ Review:
After ASQ completes the review process you will receive an approval notification via email or a "hold" message explaining that more information is needed for your application to be approved. If it is determined that you do not meet exam requirements, you will receive a refund minus a $70 processing fee.

3. Testing Options
a. Computer-Based Testing, CBT:

1-2 business days after you receive your approval notification, you will receive an eligibility email containing instructions on how to schedule your exam with our testing provider Prometric.

b. Paper-Based Testing, PBT:
If you have registered for a Paper-based or translated exam you will not receive an eligibility email. Instead you will receive a seating letter with your exam date, time, and location approximately 2 weeks before your exam date.

4. Schedule your exam with Prometric:
Schedule your exam appointment in the testing window you chose at the time of application.


ASQ certification examinations are delivered by ASQ's testing partner, Prometric.

The examination scheduling instructions in your eligibility letter will direct you to a section of Prometric's website, where you can select and schedule your examination date and location.

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